North America and Europe Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market Rising Impressive Business Opportunities Analysis Forecast By 2026

Acute bacterial skin and skin structure infections (ABSSSI) are the skin and soft tissue infections that affect the epidermis, dermis, and subcutaneous tissues. The U.S. FDA defines ABSSSI as lesions with cellulitis/erysipelas, wound infections, and major cutaneous abscesses occurring in a minimum surface area of 75 cm2. Increasing number of ambulatory patients seeking treatment for skin and skin structure infections will further propel growth of the ABSSSI market. For instance, according to Decision Resource Group, in 2014, 11% of 2.7 million hospital admissions for ABSSSI were pediatric patients. The increasing pediatric patient pool is targeted by the manufacturers to enhance its product portfolio with pediatric specific products. For instance, in 2016, Allergan plc received US FDA approval for its supplemental New Drug Application (sNDA) for Teflaro, for ABSSSI indication in pediatric.
Key players operating in the North America and Europe Acute Bacterial Skin and Skin Structure Infections (ABSSSI) market are Merck & Co., Inc., Pfizer Inc., GlaxoSmithKline plc, Teva Pharmaceutical Industries Ltd., Paratek Pharmaceuticals, Inc., Melinta Therapeutics, Inc., Arrevus, Inc., AbbVie Inc., Aurobindo Pharma Ltd., Amneal Pharmaceuticals LLC, and Sun Pharmaceutical Industries Ltd.

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Market Dynamics

The major market driver for growth of North America and Europe Acute Bacterial Skin and Skin Structure Infections (ABSSSI) market is increasing research and development activities by pharmaceutical and biopharmaceutical companies to develop new products and novel treatment. For instance, in 2017, Cempra announced promising data from the phase 3 trial of Fusidic acid for the treatment of ABSSSI. In same year, Melinta Therapeutics received U.S. FDA for its product Baxdela, a delafloxacin based ABSSSI medicine, available in both intravenous and oral formulations. Moreover, in 2018, Fresenius Kabi received U.S. FDA approval for new drug application of daptomycin, a lipopeptide class of antibacterial drug, in injectable form for complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria such as Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactlae etc.

However, misuse of drugs causes antibiotic resistance which is a major factor hindering growth of the North America and Europe acute bacterial skin and skin structure infections (ABSSSI) market. For example, according to the Centers for Disease Control and Prevention data has shown that treatment indication, choice of agent, or duration of antibiotic therapy is incorrect in 30-50% of cases. Moreover, 30-60% of antibiotics prescribed in intensive care units (ICUs) have been found to be unnecessary, inappropriate, or suboptimal.

Acute bacterial skin and skin structure infections (ABSSSI) are the type of skin and soft tissue infections that affect the epidermis, dermis, and subcutaneous tissues. The U.S. FDA defines ABSSSI as lesions with cellulitis/erysipelas, wound infections, and major cutaneous abscesses occurring in a minimum surface area of 75 cm2. Pathogens such as Methicillin sensitive Staphylococcus aureus (MSSA), Methicillin resistant Staphylococcus aureus (MRSA), Beta-hemolytic Streptococcus, Escherichia coli, Enterococcus faecalis, and Pseudomonas aeruginosa are the major causes of ABSSSI. This infection is difficult to treat due to increasing prevalence of drug resistant strains, especially in Staphylococcus spp. and Enterococcus spp. The ABSSSI market is expected to witness moderate growth owing to the increasing number of patients suffering from skin infections and large number of pipeline products, which are expected to receive approval during the forecast period.

North America and Europe Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market – Impact of Coronavirus (COVID-19) Pandemic

Acute bacterial skin and skin structure infections (ABSSSI) antibiotics treatment is required for majority of patients with severe bacterial skin infection and the treatment might be delayed due to the pandemic. Although, during the COVID-19 pandemic, the antibiotic treatment of ABSSSI patients is often postponed or even cancelled due to the unavailability of ABSSSI antibiotics and irregular supply and transportation of products. Moreover, according to a study published in the Antimicrobial Agents and Chemotherapy journal, the monthly use of antibiotic therapy from March through June 2020 decreased by 151.5% per month compared with January 2018 through February 2020 - a 6.5% monthly reduction in use of antibiotics.

The North America and Europe acute bacterial skin and skin structure infections (ABSSSI) market is estimated to be valued at US$ 1,283.8 million in 2020 and is expected to exhibit a CAGR of 3.9% during the forecast period (2020-2027).
Increasing research and development activities are expected to boost growth of the North America and Europe Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market.

The major driver for the growth of the North America and Europe acute bacterial skin and skin structure infections (ABSSSI) market is research and development of products and novel treatments by pharmaceutical and biopharmaceutical companies. For instance, in August 2019, Basilea Pharmaceutica Ltd. announced positive topline results for the phase 3 TARGET study, evaluating ceftobiprole in the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Ceftobiprole medocaril, is a cephalosporin antibiotic for intravenous administration with rapid bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria. This includes methicillin-susceptible and resistant Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas spp. Ceftobiprole is currently in phase 3 clinical development for a potential registration in the U.S., with a completed study in acute bacterial skin and skin structure infections (ABSSSI) and an ongoing study in Staphylococcus aureus bacteremia (SAB).

Furthermore, several key players in the market are focused on obtaining product approvals and launching them in the market to provide better treatment options for ABSSSI. This is expected to significantly drive growth of the North America and Europe ABSSSIs market in near future. For instance, in October 2018, Paratek Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved NUZYRA (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). NUZYRA, a modernized tetracycline, is a once-daily IV and oral antibiotic that exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and drug resistant strains.
North America and Europe Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market – Restraints

Patent expiration of ABSSSI antibiotic drugs is a major factor restraining growth of the North America and Europe acute bacterial skin and skin structure infections (ABSSSI) market. According to the Centers for Disease Control and Prevention, the World Health Organization, and U.S. and European governments, patent expiration leads to the production of low priced and low cost generic drugs are easily accessible which leads to their overuse and misuse. Bacteria evolve when subjected to selective pressure and multi-antibiotic resistance in organisms as ubiquitous as Escherichia coli and Staphylococcus aureus has been observed. Furthermore, patent expiry has led low cost generic drugs to dominate the market and misuse of drugs.

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North America and Europe Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market – Regional Analysis

North America is expected to hold dominant position in the North America and Europe Acute Bacterial Skin and Skin Structure Infections (ABSSSI) market. Launch of products by key players is propelling growth of the North America acute bacterial skin and skin structure infections (ABSSSI) market. For instance, in June 2018, Melinta Therapeutics, Inc., a commercial-stage company focused on developing and commercializing novel antibiotics to treat serious bacterial infections, announced the U.S. launch of intravenous and oral formulations of Baxdela (delafloxacin) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.

Europe is expected to witness significant growth in the market due to increasing number of product approvals. For instance, in August 2016, Cardiome Pharma Corp. announced that XYDALBA (dalbavancin) has been approved by the European Medicines Agency (EMA) for administration as a single, 30 minute, 1500 mg infusion (three 500mg vials) as a treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) in adults.

North America and Europe Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market - Competitive Landscape

Key players operating in the North America and Europe Acute Bacterial Skin and Skin Structure Infections (ABSSSI) market are Merck & Co., Inc., Pfizer Inc., GlaxoSmithKline plc, Teva Pharmaceutical Industries Ltd., Paratek Pharmaceuticals, Inc., Melinta Therapeutics, Inc., Arrevus, Inc., AbbVie Inc., Aurobindo Pharma Ltd., Amneal Pharmaceuticals LLC, and Sun Pharmaceutical Industries Ltd.

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